Evaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS

← catalyst calendar

NCT04057898 · readout ≤ 254 d

Sponsored by MediciNova (industry) · MNOV — their whole pipeline →.

Phase

Phase 2/3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

234actual

Sites

Countries

Canada, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2020-05-28

actual

When the study began enrolling

Primary completion

Apr 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Apr 2028

estimated

The whole study's end, after follow-up

First posted

2019-08-15

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-03-06

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Amyotrophic Lateral Sclerosis

Interventions

Drug: MN-166 — also filed as ibudilast
Drug: placebo

Primary outcome

what the primary-completion date above is the date OF

Change from baseline in ALSFRS-R score at Month 12 (or last measurement before death in case of censoring) and survival time.

measured 12 months

Publications

PMID 36008843 — linked by the registry
PMID 34816762 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

Permalink · MNOV's whole pipeline · Catalyst calendar · Every registered study · What changed